Senior Director Quality Operations

Senior Director, Quality Operations – Clinical Chemistry Immunoassay (CCIA) North America provides senior‑level operational quality leadership for the Chaska, Minnesota and San Diego, California manufacturing and development sites, with accountability for manufacturing quality and development quality. This role translates enterprise quality strategy into disciplined site execution, ensures regulatory compliance, and drives a strong culture of quality across CCIA through close partnership with Operations, R&D, Supply Chain, and Regulatory Affairs.

This position reports to the Vice President, US Quality Operations and is a key member of the North America Quality Operations leadership team and will be based out of Chaska, Minnesota.

• Provide strategic and operational quality leadership for the Chaska site and Carlsbad sites, driving a strong culture of quality across the CCIA organization and establishing followership through influence and matrixed collaboration with cross‑functional partners.
• Lead and be accountable for a complex, multi‑disciplinary quality organization, including Quality Assurance, Quality Control, Process Validation, Design Quality, Incoming Inspection, and sustained deployment of the Danaher Business System (DBS) to drive standard work, problem solving, and continuous improvement.
• Ensure sustained compliance with the Quality Management System (QMS) and applicable regulatory requirements, partnering with global and local stakeholders to standardize, simplify, and continuously improve quality processes.
• Own site quality performance and key performance indicators, proactively identifying gaps and leading structured problem‑solving to resolution when performance is at risk.
• Build and sustain an effective quality organization by ensuring appropriate staffing levels, clear role design, capability depth, succession coverage, and overseeing budget allocations required to consistently meet site performance, compliance, and delivery commitments.
• Build, mentor, and develop strong, diverse teams and quality leaders, fostering engagement, accountability, and leadership behaviors that inspire followership and ownership at all levels of the organization.
• Collaborate across all organizational levels, functions, and management chains to align priorities, communicate risk, and drive timely decisions to solution that protect patient safety and ensure the delivery of safe, compliant, high‑quality diagnostic products.

• Bachelor’s degree in a scientific or engineering discipline with 20+ years of experience, or Master’s/Doctoral degree with 18+ years of experience, including 6+ years of people leadership experience.
• Minimum of 10 years of quality leadership experience with in‑vitro diagnostics or medical device industry, with direct accountability for manufacturing and/or development quality.
• Demonstrated experience leading quality organizations at multi‑site or complex manufacturing environments, including responsibility for compliance, inspections, and operational performance.
• Deep working knowledge of quality assurance, quality control, process validation, design quality, and supplier/incoming quality within regulated industries.
• Strong understanding of IVD regulatory requirements and quality standards (e.g., FDA, ISO, global regulatory frameworks).
• Proven ability to lead structured problem solving, apply data and risk‑based decision making, and drive sustainable corrective actions.

• Ability to travel – up to 35% domestically and internationally per business needs.

• Leading regulatory inspections, audits, or remediation activities in a regulated diagnostics or medical device environment.
• Applying DBS or similar continuous improvement systems to improve quality performance and simplify processes.
• Supporting new product introductions or product transfers, partnering with R&D and Operations to ensure compliant commercialization.

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